The field of art to which this invention relates is packaging machinery, in particular, machinery for loading surgical sutures into packages.
Surgical sutures having surgical needles attached to one or both ends are well known in the medical arts. Sutures having a single needle attached to one end are known as single-armed sutures. While sutures having needles attached to both ends are known as double-armed sutures. Sutures not having surgical needles mounted to an end are referred to as unarmed sutures. Double-armed sutures find particular utility in the following types of surgical procedures: cardiac valve replacement surgery, cardiac surgery, and bowel surgery.
In the past, surgical sutures were hand packaged into specially designed suture packages. Typically, the sutures were wound using conventional winding fixtures having winding pins. Although there may have been advantages associated with the hand winding methods of the prior art, one major disadvantage was that they were unnecessarily time consuming. In order to maintain high quality and to reduce costs, manufacturers of surgical sutures and surgical needles have developed high-speed packaging processes for packaging surgical needles and sutures into specially designed packages. Examples of packages which can be used in high speed winding applications are contained in U.S. Pat. Nos. 5,213,210, 5,236,083, 5,284,240, 6,098,796, and 6,135,272, the disclosures of which are incorporated by reference. High speed winding machines for packaging surgical sutures in such surgical suture packages are disclosed for example in U.S. Pat. Nos. 5,664,404 and 6,032,343 which are incorporated by reference.
Although the packaging machines and processes of the prior art are adequate for their intended use, there are certain types of surgical sutures which are particularly difficult to adapt to high speed winding or packaging machine operations. For example, suture for use in cardiac and cardiovascular surgical procedures is very delicate and any damage caused to the suture by handling or packaging can compromise the integrity of the sutures. In addition, it has been difficult to package such sutures in packages using high-speed automatic packaging machinery due in part to the fine gauge of the sutures. Also, it previously has not been possible to package double armed sutures in tray packages using high-speed winding equipment.
Accordingly, there is a need in this art for novel high-speed packaging machinery and processes for packaging surgical needles and sutures.
Therefore, it is an object of the present invention to provide novel, high-speed packaging machines for packaging surgical needles and sutures in tray packages.
Yet another object of the present invention is to provide such novel high-speed packaging machines having the capability of packaging single-armed, doubled-armed and unarmed surgical sutures.
It is yet another object of the present to provide novel processes for packaging surgical needles and sutures.
Accordingly, a high-speed suture packaging machine for packaging surgical needles and sutures in tray packages is disclosed. The machine has a frame having a top, a bottom, sides and an interior. A disc member or turret is rotatably mounted to the top of the frame, said disc member having a periphery, top, a bottom and a side about the periphery of the disc member. The disc member may be rotated or indexed to a plurality of index positions. A plurality of tool nests is mounted to the top of the disc. Each tool nest is rotatably mounted to the top of the disc member. The tool nests have a nest frame, having a top, a bottom and sides. At least two winding pin members extend up from the top of the nest frame. A rotatable tool mounted to the frame, said tool being displaceable downwardly to engage with the pin members on the nest frame, such that rotation of the tool will rotate the tool nest. A stylus member is movably mounted to the machine frame, for cooperation and engagement with the tool nests. The stylus comprises a frame having a top, sides and a bottom. A stylus is mounted to the bottom of the frame having a front nose member and a rear heel member separated by a suture opening. The stylus has a top surface. A door closing member extends down from the bottom of the frame adjacent to the stylus. A tray package mounted to the winding pins on place on top of the tool nest frame is rotated to wind sutures in a winding channel in the package.
Yet another aspect of the present invention is the combination of the afore-mentioned packaging machine and a suture tray package. The package has a flat base member having a top and an outer periphery. An outer wall extends up from the base member about the periphery of the base member. An inner wall, interior to the outer wall, extends up from the top of the base member. The inner wall having a top and said inner wall space away from the outer wall to form a suture channel. A plurality of doors extend from the top of the inner wall over the winding channel. At least two needle park members extend up from the top of the base member. The needle park members are located interior to the inner wall. Initially, the tray package is mounted on the winding pins to the top of the tool nest. A tray package is mounted to the top of a tool nest. Then the disc member is indexed to a suture loading station wherein both needles of a double armed suture are mounted into the needle parks of the tray package thereby forming a loop in the suture. Next, the tool nest is indexed to the machine winding station wherein the tool nest is engaged by a rotating tool, thereby rotating the tool nest and package and causing the suture loop to be wound in the suture channel.
Yet another aspect of the present invention is a method of winding a double-armed suture in a tray package using the afore-described packaging machine of the present invention. The method consists of providing the packaging machine of the present invention along with a tray package having a winding channel, and also providing a double armed suture.
These and other features, advantages and attributes of the present invention will become more apparent from the following description and accompanying drawings.